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Senior Quality Assurance Director
2 months ago
We are seeking a highly experienced and skilled Senior Quality Assurance Director to lead our Quality Technical Services department. As a key member of our team, you will be responsible for developing and implementing innovative quality systems and approaches, leading a team of quality engineers and validation engineers, and ensuring compliance with regulatory requirements.
Key Responsibilities- Develop and implement practical, sustainable, and efficient quality systems and approaches
- Lead a team of quality engineers and validation engineers to provide guidance for investigations, recommend solutions using risk-based techniques, and perform testing protocols
- Drive reduction of the cost of poor quality through lower scrap rates, reduced rework, and more effective process control
- Promote compliance improvement through education, strategic project initiatives, and organizing compliance activities
- Manage validation activities, validation of site continuous improvement projects, and validation activities defined in the Site Master Validation Plan
- Bachelor's Degree in a technical or science-related field
- Minimum 10 years of experience in a regulated industry with 5 years of experience in quality or validation work
- Excellent written and oral communication skills to interact across all levels of the organization
- Expert skillset of risk analysis, problem-solving, statistical methods, and detail-oriented technical writing
- Experience leading people, projects, and teams with the ability to work with limited supervision and to take initiative to ensure timely completion of tasks
bioMerieux Inc. is a world leader in the field of in vitro diagnostics for more than 60 years. We provide diagnostic solutions that determine the source of disease and contamination to improve patient health and ensure consumer safety. We are a family-owned global company with a long-term vision and a human-centered culture.